Gene Patents in India
K M Gopakumar (TWN) and Visalakshi (Centad)
Introduction
The question of patenting of life forms came up in India in the context of India’s
ratification of the Final Act of the Uruguay Round, which established the World
Trade organisation. In order to comply with the provisions of the TRIPS
Agreement India amended the Patents Act 1970 in 2002 to introduce patent for
life forms. This Act was came into force in 2003 after three years from the
original deadline to introduce patent protection for life forms under the
Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS),
which is part of the e final Act of Uruguay Round.
Prior to the amendment Indian Patent Act 1970 denied patent protection to life
forms. Even though there was no explicit prohibition against the patenting of life
forms Section 3 of the Patents Act, which exclude certain inventions from patent
protection. According to Section 3 invention contrary to morality, agriculture
and horticulture and treatment of plant and animals were denied patents.
However, the
This short note explains the current status of biotech patents especially
patenting of genes in India. First Part explains the legal provisions on patenting
of life forms in India. Second Part discusses the practise of the patent office and
the last part provides some empirical evidence and the last part contains certain
specific suggestions.
Options for the Implementation of Article 27 (3) (b) of TRIPS
One of the dominant strategies to implementation of the TRIPS obligation was to
use the flexibilities available in the TRIPS agreement. At least five types of
flexibilities are available in the implementation of Article 27 (3). First, since
there is no definition of invention is provided in the TRIPS Agreement, there is a
possibility to make legal difference between invention and discovery and to
exclude naturally found microorganisms and other genetic material form the
patent protection. Second, flexibility is again comes form the absence of
definition of microorganism. Hence, there is a possibility to define
microorganisms as a living single cell organism and to exclude part of the plants
and animals from patent protection. Third, is to exclude patents on certain life
forms including genes using the exception under Article 27 (2) of the TRIPS
Agreement, which allows exclusion of patent on public morality. 1 Four establish
Members may exclude from patentability inventions, the prevention
within their territory of the commercial exploitation of which is
necessary to protect ordre public or morality, including to protect
human, animal or plant life or health or to avoid serious prejudice to
1
a high threshold level of inventive step criteria and avoid patenting of naturally
found bi materials including genes. Five, implement high threshold level for the
industrial application criteria and to deny patent on naturally found bio
materials including genes.
Prior to discuss the limitations on these approaches it is also important to
consider the basic limitations in developing countries, which would limit the
implementation of TRIPS flexibility. Often it is assumed that every WTO Member
State has a same level of progress in science and technology and therefore there
is level playing field in terms of understanding the complexities related to
patenting of biotechnology. However, the reality there is lack of capacity in many
developing countries to understand the development implications of
biotechnology in general and especially on the issue of patenting of
biotechnology. Second, there is no shared understanding existing among WTO
Members with regard to the actual scope of TRIPS flexibilities. This would
provide a room for vested interest especially from the developed countries to
influence the law and policy framework to minimise the use of TRIPS flexibilities.
Often developing country patent laws fails to include pre-grant stage flexibilities
to the optimum level. Lastly, there is an asymmetry existing among patent office
in terms of their financial and human resource and infrastructure. There fore it
would be difficult for many developing country patent offices to implement the
flexibilities especially those available at the pre-grant stages of patents.
Implementation of the above-mentioned flexibilities depends on the ability of the
patent office to apply the flexibilities provided in the domestic law. Generally
speaking, these flexibilities can be incorporated in the domestic law in two ways.
First, entrusting the patent office to apply the exclusion on a case-to-case basis
and determine whether the claimed invention falls within the exclusion. For
instance, a broad exclusion of certain invention on the ground public morality. In
such cases patent office or the judiciary has to examine whether the claimed
invention falls within the exclusion. The problem with this approach is that
success depends on the capability of the patent office to apply the law correctly
in real context. Further, it also potentially generates litigation and an
opportunity for the judiciary to interpret the law, which may go against the
policy objective behind the exclusion. Second, to eliminate or limit the freedom
of judiciary and the patent office to interpret the law and exclude certain
inventions very clearly in the statute. For instance, certain patent statute
excludes new use of known substance from patent protection.
Considering the inherent capacity deficit in developing countries it is in the
interest of the developing countries to exclude explicitly all possible exclusions
in the statute on the basis of above mentioned flexibilities.
the environment, provided that such exclusion is not made merely
because the exploitation is prohibited by their law
Scope of Patent Protection
In order to comply with the three amendments were carried out on the Patents
Act 1970 viz 1999, 2002 and 2005. The last two amendments carried out
changes in the definition of patentable criteria and exclusion of patents.
Generally speaking, there are two ways to limit the scope of patentability. First, to
increase the threshold limit of patentability criteria by providing the definition of
patentability criteria, viz. novelty, inventive step and industrial applications. Second,
to exclude certain types of inventions, which do not satisfy any one of the
patentability criteria, or those inventions, which are in conflict with public morality,
national security or affecting the health of humans, animals and plants. The Indian
Patents Act attempts to limit the scope of patentability by following both methods.
The criteria for patentability are defined in the Act and linked to a web of definitions.
According to the Act, a patent means “a patent for any invention granted under this
Act”.2 The word ‘invention’ is defined as a “new product or process involving an
inventive step and capable of industrial application”.3 Thus a patent is granted only to
a new product or process involving an inventive step and capable of industrial
application. However, the Act defines ‘inventive step’ as “a feature of an invention
that involves technical advances as compared to the existing knowledge or having
economic significance or both and that makes an invention not obvious to a person
skilled in the art”.4 According to this definition, to qualify the inventive step test the
invention has to satisfy any of the three conditions, viz. advances over existing
technical knowledge or economic significance or both. Generally speaking, economic
significance should not be a sole criterion for evaluating the inventive step of the
invention. The economic significance of an invention depends on many other factors
and it is not the purpose of patents to recognise economic significance of an
invention. However, the new definition makes the economic significance criteria as
substitutable criteria to technical effect. As a result, the new definition of inventive
step diluted one of the basic requirements of an inventive step. TRIPS uses economic
significance in a different context. Under Article 31(l) (ii), TRIPS states that
compulsory licence for dependent patent should look at whether the second patent
should involve an important technical advance of considerable economic significance
in relation to the invention claimed. Therefore, economic significance could have
been used along with the technical effect to judge the inventive step, but not as the
sole criteria. Therefore, the current definition lowers the threshold level for the
inventive step. In short these changes in the definitions does not offer any limitation
on the scope of bio technology inventions including patenting of genes.
The Section 3 of the Patents Act excludes 16 categories of inventions from patent
protection, because they are not considered inventions within the definition of
invention. Since these 16 items are not qualified as inventions within the scope of
Patents Act claims falls within these 16 items are excluded form patent protection.
There are a few exclusions having implications to the patentability of which can
applied in the context of biotechnological invention. However the most important
2
Section 2 (m) of Patents Act.
3
Section 2( j) of Patents Act.
4
Section 2(ja) of Patents Act.
section for our discussion is Section 3 (b) and 3 (j). According to Section 3(b) an
invention which primary intention is commercial exploitation
QuickTime™ and a
decompressor
are needed to see this picture.
Section 3 (j) states that
QuickTime™ and a
decompressor
are needed to see this picture.
Section 3 (j) is a clear that any part of the plant r animals cannot be patented. Thus a
plant and animal or nay part of it is not patentable. Even though there is no explicit
exclusion of genes or DNAs under this section. However, it is clear that this exclusion
includes gene, cell lines, DNA etc.
But the practise of patent office suggest that patent office does not share the view that
patent claims falls within Section 3 (j) of the Patents Act. For instance, the Draft
Patent Manual practise and Procedure 2008 and 2011 edition does not provide nay
explanation on Section 3 (j). However the manual while explaining the unity of
invention states:
(iv) When a genetically modified Gene Sequence/ Amino Acid Sequence is
novel, involves an inventive step and has industrial application, the
following can be claimed.
(a) Gene sequence / Amino Acid sequence
(b) A method of expressing above sequence
(c) An antibody against that protein / sequence
(d) A kit made from the antibody / sequence
All of these claims are linked by the inventive concept if the genetically
modified sequence is new, inventive and has industrial application
This clearly shows that patent for genes are available in India irrespective
Section 3 (j). This in a way may be the result of indirect harmonization
happening between developed and developing countries. Instead of developing a
development oriented jurisprudence developing country patent office looked at
developed country patent office for guidance in these areas. This resulted in
importation of jurisprudence form developed countries and resulted in the
practical harmonization of patent law. As a result the statutory provisions
remained only in the statute book without any practical use.
For instance, In order to enhance the capacity, the patent office entered into
eight Memorandum of Understandings (MoUs) with the developed countries.5 All
5
Indian Patent Office signed MoUs with IP or patent offices of Australia, Germany, Switzerland,
Japan, the UK, the US, France and the European Patent Office (EPO).
these eight countries are advocates of enhanced patented protection and compromise
the strict patentability standards. These MoUs cover human resource development,
capacity building activities, exchange of best practices and information exchange.
This would lead to importation of the developed country practices through
examination process and training of examiners. For instance, the patent office MoU
with the US Patent Office (USPTO) states that
The Parties shall work together in capacity building in Intellectual
Property Rights including automation and modernization of
Intellectual Property Offices, development of databases, and
procedural rationalization and simplification of processing of
Intellectual Property applications, inter alia, through the exchange of
information on patent data, best practices in patent examination
procedures, etc.
The two Parties shall cooperate in the training of personnel and
human resource development in the area of Intellectual Property
Rights with a view to strengthening the working of the Intellectual
Property (IP) systems in the two countries, including in patent
examination training.6
As part of the MoU, nearly many patent examiners were trained under USPTO. Hence
the manual brings a backdoor harmonization of patent examination standards with the
US and the EU patent examination practices. These trainings might have resulted in
the above-mentioned interpretation on gene patents in the Manual.
During the last 5 years there is an increase in the biotech patent application and
its grant. Annual Report provides patent applications received in biotechnology,
biomedical, biochemistry and agriculture. The last five years has witnessed an
increase in the number of patent application sin these areas. According to the
Annual Report of the Indian Patents Office number of biotechnology application
has increased form 1214 (2004-08) to 1884 (2008-09). The number patent
applications in other related areas are: bio medical application (1106 foreign 68
Indian) , . Bio Chemistry (759 foreign and 119 Indian), Bio informatics (60
foreign and 4 Indian), Agriculture 59 foreign and 29 Indian ).
There is also an increase in the number of patents granted in biotechnology
sector. During 2004-05 patent office granted only 71-bio technology. This has
increased to 1157 2008-09. The numbers of patents granted in new areas are :
bio medical application (244 foreign 19 Indian) , Bio Chemistry (1587 foreign
and 198 Indian), Bio informatics (0), Agriculture (16 foreign and 4Indian ).
However, empirical analyses of granted patents 2005-2008 June shows that
patent office granted claims on genes. This analysis was carried out on the basis
of scrutiny of title and abstract search. Prima facie suspected gene patents are
6
Articles 3 and 4 of MoU on Bilateral Cooperation between Controller General of Patents, Designs
and Trade Mark and the United States Patent and Trade Mark Office, available at:
<http://dipp.nic.in/acts/MOU_of_bilateral_cooperation_with_usa.pdf>, accessed on 25 October 2009.
taken up for further analyses, this part is currently under progress. However the
preliminary analyses shows that patent have been granted on genes. Annex 1
provides a sample list of such patents.
Way Forward
Over the years there is an increasing number of pockets of resistance to
patenting n life as well as gene. However, the challenge is to translate these
resistances into concrete policy action. The following are some of the
suggestions.
First, in the light of the 15 years of experience there should be pressure on WTO
Member sates to carry out the mandatory review under Article 27 (3) (b) and 71.
Article 27 (3) (b) states that “The provisions of this subparagraph shall be
reviewed four years after the date of entry into force of the WTO
Agreement”. Hence the scope of this review is broad and the question
of life patenting should be opened up. In the past African Group put
up a proposal to ban the life patents. Of late there is a revival of
interest on this issue among some of the WTO Member sates and it
may be translated into fresh proposals. Similarly, Article 71 also
mandates a review of the implementation of the whole Agreement.
These two reviews are also reflected in the Doha mandate.
Second, there is also attempt to lock in more countries with TRIPS
Plus commitments on the scope of patent protection and reduces their
policy space. For instance, Japan Thailand FTA Article 130 states that
“Each Party shall ensure that any patent application shall not be rejected solely on
the grounds that the subject matter claimed in the application is related to a
naturally occurring micro-organism”. This would make it difficult for Thailand to
reject isolated genes from patent protection.
Third, it is important to facilitate the actual use of TRIPS flexibilities in developing
countries. In the absence of such effort developed countries would attempt to
harmonise the patent examination procedures and virtually eliminate the policy
space existing in law to deny patent on certain types of claims including genes. As
shown above this is happening even in countries like India. One suggestion in this
regard is to prepare a manual of patent examination on life form from a public
interest angle analysing the various types of patent claims and its patentability
under the existing TRIPS flexibilities. This would help many developing country
patent offices to apply the flexibilities at the time of examination.
Annex 1
no. Pat
ent
no.
Applicatio
n no.
Title of Invention
Name of the Patentee
213
698
216
702
216
568
213
110
214
298
218
538
993/MUM/
2002
PROCESS FOR
PRODUCING
RECOMBINANT
HUMAN SERUM
ALBUMIN IN
PICHIA PASTORIS
BY A NOVEL GENE
AND ITS
PHARMACEUTICAL
USES
IN/PCT/200 BACTERIA
0/00216/D ATTENUATED BY A
EL
NON-REVERTING
MUTATION IN
EACH OF THE
AROC, OMPF AND
OMPC GENES,
USEFUL AS
VACCINES
IN/PCT/200 A CHIMERIC GENE
1/00062/M COMPRISING A
UM
NUCLEIC ACID
FRAGMENT
CONFERRING
DISEASE
RESISTANCE TO
PLANTS
466/CHENP TRANSCRIPTIONAL
/2005
ACTIVATOR GENE
FOR GENES
INVOLVED IN
COBALAMIN
BIOSYNTHESIS
697/CHENP NOVEL SERINE
/2003
PROTEASE GENES
RELATED TO
DPPIV
CADILA HEALTHCARE
LIMITED
01519/KOL
NP/2004
UNIVERSITY OF TSUKUBA
NOVEL ROOT
KNOT NEMATODE
RESISTANCE GENE
AND APPLICATION
THEREOF
PEPTIDE THERAPEUTICS
LIMITED
E.I.DU PONT DE NEMOURS
AND COMPANY
GEYMONAT S.P.A.
FERRING BV
219
556
01628/KOL
NP/2003
VECTOR
ENCODING HUMAN
GLOBIN GENE AND
USE THEREOF IN
TREATMENT OF
HEMOGLOBINOPA
THIES
CLONING AND
SEQUENCING OF
AGTSAL11 RICE
GENE FROM IR-64
VARIETY
IMPLICATED IN
SALINITY STRESS
TOLERANCE
SLOAN KETTERING
INSTITUTE FOR CANCER
RESEARCH
022
72
997/MAS/1
999
20910
4
1074/DELNP/20
03
"A CHIMERIC CR3 GENE
CONTAINING
FRAGMENTS FROM
DIFFERNT HIV-1
GENES"
CENTRO DE INGENIERIA
GENETICA Y BIOTECHNOLOGIA
21047
5
600/MUMNP/20
05
THE GENE CLUSTER
INVOLVED IN
SAFRACIN
BIOSYNTHESIS AND ITS
USES FOR GENETIC
ENGINEERING
PHARMA MAR S.A
AVESTHA GENGRAINE
TECHNOLOGIES PRIVATE
LIMITED, AN INDIAN
COMPANY